iMedi.co.uk

Allertek 10mg Tablets

TEVA UK Ref: 231-30-20239-F LEA ALLERTEK (CETIRIZINE) 10mg TAB RAT1OPHARM <MER Version: 1    06 August 2015

Patient Information Leaflet


AllerTek 10mg Tablets

cetirizine dihydrochloride


ratiopharm


Read all of this leaflet carefully before you start taking this medicine.

•    This medicine is available without prescription. However, you still need to use this medicine carefully to get the best results from it.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve after 7 days.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. This includes any side effects not listed in the leaflet. See section 4.


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In this leaflet:

1.    What AllerTek 10mg Tablets are and what they are used for

2.    What you need to know before you take AllerTek 10mgTablets

3.    How to take AllerTek 10mgTablets

4.    Possible side effects

5.    How to store AllerTek 10mg Tablets

6.    Contents of the pack and other information

1.    What AllerTek 10mg Tablets are and what they are used for

Cetirizine dihydrochloride is an antihistamine for the treatment of allergic diseases.

This medicine acts by blocking the effect of histamine, which is involved in the development of the allergic reaction.

Cetirizine dihydrochloride is used for the treatment of symptoms in the following allergic diseases:

Adults and children over 6 years:

Seasonal and non-seasonal allergic rhinitis (sneezing, itchy, runny and blocked up nose), allergic inflammation of the eyes (itchy, red and watering eyes) and urticaria (swelling, redness and itchiness of the skin).

2.    What you need to know before you take AllerTek 10mg Tablets

Do not take this medicine and tell your doctor

•    If you are allergic (hypersensitive) to cetirizine dihydrochloride or any of the other ingredients of this medicine, or to hydroxyzine or piperazine derivatives (closely related active substances of other medicines).

•    If you have severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min).

You should not take this medicine

If you have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Warnings and precautions

Take special care with this medicine and tell your doctor

•    If you are receiving long-term treatment with this medicine.There is an increased risk of tooth decay due to dryness of the mouth. So it is important that you brush your teeth regularly to help prevent tooth decay.

•    If you have liver or kidney problems (your doctor will decide whether you need to take a lower dose).

•    If you are an epileptic patient or a patient at risk of convulsions.

•    If you have urinary retention problem Children

This medicine is not intended for use in children under 6 years of age.This product is also available as a solution that would be more suitable for this age group.

Other medicine and Cetirizine

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you are having an allergy test you must stop taking your tablets three days before the test as the tablets may affect the results.

This medicine can increase the effect of medicines that are used to treat the central nervous system.

Cetirizine with food and drink This medicine can influence the effect of alcohol. You are advised to avoid drinking large amounts of alcohol whilst taking this medicine.

Pregnancy, breast-feeding and fertility

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

You should let your doctor know if you are pregnant or think you might be pregnant before taking this medicine.Your doctor will decide if this medicine is suitable for you.

Breast-feeding

You should therefore not take this medicine if you are breast-feeding, because cetirizine passes into breast milk.

Driving and using machines

This medicine can make you feel drowsy and therefore affect the ability to drive or use machines safely. Therefore avoid driving or using dangerous machines until you know how this medicine affects you.

Important information about some of the ingredients of AllerTek 10mg Tablets

This medicine contains lactose. If you have been told by your doctor, that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.    How to take AllerTek 10mg Tablets

Always take this medicine exactly as prescribed in this package leaflet.You should check with your doctor or pharmacist if you are not sure.

The usual dose for adults and children over 12 years:

1 tablet (10 mg) daily.

The usual dose for children between 6 and 12 years:

IV    a tablet (5 mg) twice a day (morning and evening).

The usual dose for children under 30 kg:

V    tablet (5 mg) once daily.

Patients with moderate to severe kidney impairment:

Patients with moderate renal impairment are recommended to take V tablet (5mg) once daily.

Do not exceed the stated dose.

The tablet should preferably be swallowed with liquid (e.g. a glass of water). If the tablets make you drowsy you may take them in the evening.The tablets can be taken with or without food.

If you have the impression that the effects of this medicine are too strong or too weak, talk to your doctor or pharmacist.

If you take more AllerTek 10mg Tablets than you should

If you take a larger dose than recommended, consult your doctor immediately.

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You may feel dizzy, drowsy, sleepy, have a headache, have difficulty with muscle coordination, a racing heart-beat, be excitable (children in particular), have a dry mouth, muscle tremor, flushed face and neck, diarrhoea, and difficulty passing urine. If you forget to take AllerTek 10mg Tablets

Do not take a double dose to make up for a forgotten tablet/dose.

The treatment should be continued as normal.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen, stop taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital:

Anaphylactic shock (sudden life-threatening allergic reaction). Symptoms include rash, itching or hives on the skin; swelling of the face, lips, mouth, tongue or other parts of the body; difficulty swallowing, shortness of breath, wheezing or trouble breathing.

These are very serious side effects. If you have them, you may have had a serious allergic reaction. You may need urgent medical attention or hospitalisation. All of these very serious side effects are very rare (fewer than 1 in 10,000 patients treated). Stop taking this medicine and seek medical attention as soon as possible if you experience any of the following side effects:

Fixed drug eruption (a skin reaction that erupts every time the drug is taken, in the same place on the body.The skin rash is usually preceded by itching or burning, then erupts as a raised dusky red or purple-tinged patch of skin. The affected skin may blister as well. Common locations are the hands and feet, lips, and genitalia) (this side effect is very rare (fewer than 1 in 10,000 patients treated)) or hypersensitivity (excessive, undesirable - damaging, discomfort-producing and sometimes fatal reactions produced by the normal immune system) (this side effect is rare (fewer than 1 in 1,000 patients treated)).

Other possible side effects:

Common (occurs in less than 1 in 10 patients receiving this medicine):

Mouth dryness, drowsiness, dizziness, headache, sleepiness in children and adults, nausea (feeling sick), diarrhoea in children, pharyngitis (swelling of the throat), rhinitis (runny nose).

Uncommon (occurs in less than 1 in 100 patients receiving this medicine):

Agitation, diarrhoea, asthenia (unusual tiredness or weakness), malaise (generally feeling unwell), paresthesia (tingling or numbness of the hands or feet / pins and needles), itching, rash, abdominal pain

Rare (occurs in less than 1 in 1000 patients receiving this medicine):

Abnormal liver function leading to increased levels of some liver enzymes (detected by a blood test), tachycardia (heart beating too fast), weight gain, aggression, confusion, depression, hallucination, insomnia (inability to sleep), oedema (swelling of the hands, ankles, or feet), convulsions (fits), movements disorders, hives.

Very rare (occurs in less than 1 in 10,000 patients receiving this medicine):

Oculogyric crisis (a convulsive condition of the eyes in which the eyeballs become fixed, normally upwards), especially in children, accommodation disorder (difficulty focussing the eye), blurred vision, thrombocytopenia (low levels of blood platelets leading to an increased tendency to bleed or bruise more easily than normal), tic, urinary disorders such as painful or difficult urination, inability to control the flow of urine, and involuntary urination (bed wetting), fainting, tremor, dysgeusia (distortion or decrease in the sense of taste), dystonia (unusual muscle tone causing distortion of the body), dyskinesia (uncontrollable twitching, jerking or writhing movements).

Not known (frequency cannot be estimated from the available data):

Amnesia (memory loss), memory impairment, vertigo, increased appetite, urinary retention.

In very rare cases people have thoughts about committing suicide and if you feel this way then stop taking these tablets and see your doctor.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store AllerTek 10mg Tablets

Do not store above 25°C. Store in the original package.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after 'Exp:' The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.

6.    Contents of the pack and other information

What AllerTek 10mg Tablets contain

The active substance is cetirizine dihydrochloride. One tablet contains 10 mg.

The other ingredients are:

Tablet core:

Lactose monohydrate,

Microcristalline cellulose,

Colloida anhydrous silica,

Magnesium stearate.

Tablet coat:

Titanium dioxide (E171),

Hypromellose,

Macrogol 400.

What AllerTek 10mg Tablets look like and contents of the pack

White to off-white film-coated tablets, with a break-line on one side.

Blister packs containing 7 or 14 tablets.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:

ratiopharm GmbH, Graf-Arco-Strasse 3, D-89070 Ulm, Germany.

Manufacturer:

Merckle GmbH, Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren, Germany.

This leaflet was last revised in July 2015.


Version 3.3


Approved


ratiopharm

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